NDC 58593-829

Rompe Pecho EX

Guaifenesin

Rompe Pecho EX is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Efficient Laboratories Inc. The primary component is Guaifenesin.

Product ID58593-829_34e45f92-780a-44c4-9bc2-16eacb1d2b53
NDC58593-829
Product TypeHuman Otc Drug
Proprietary NameRompe Pecho EX
Generic NameGuaifenesin
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2015-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameEfficient Laboratories Inc
Substance NameGUAIFENESIN
Active Ingredient Strength100 mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 58593-829-04

118 mL in 1 BOTTLE (58593-829-04)
Marketing Start Date2019-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 58593-829-04 [58593082904]

Rompe Pecho EX LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-04-01

NDC 58593-829-06 [58593082906]

Rompe Pecho EX LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2015-01-01

Drug Details

Active Ingredients

IngredientStrength
GUAIFENESIN100 mg/5mL

OpenFDA Data

SPL SET ID:89ea23a5-0da7-407e-83d9-77a0b562f3af
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310604
  • 1112205
    • UPC Code
  • 0000856301061

    • NDC Crossover Matching brand name "Rompe Pecho EX" or generic name "Guaifenesin"

    NDCBrand NameGeneric Name
    58593-829Rompe Pecho EXRompe Pecho EX
    0363-0288childrens chest congestionGuaifenesin
    0113-0325Good Sense Mucus ERGuaifenesin
    0113-2023good sense mucus erguaifenesin
    0113-3650Good Sense Mucus ERGuaifenesin
    0113-0061good sense tussinGuaifenesin
    0121-0744GUAIFENESINGUAIFENESIN
    0121-1488GUAIFENESINGUAIFENESIN
    0121-1744GUAIFENESINGUAIFENESIN
    0121-2232GUAIFENESINGUAIFENESIN
    0363-0028GuaifenesinGuaifenesin
    0363-0033GuaifenesinGuaifenesin
    0363-0071MucusGuaifenesin
    0363-0074MucusGuaifenesin
    0363-0532Mucus ReliefGuaifenesin
    0363-0325mucus relief erGuaifenesin
    0031-9303Robitussin Direct Chest Congestionguaifenesin
    0031-8724Robitussin Mucus Plus Chest CongestionGuaifenesin
    0113-2061tussinGuaifenesin
    0363-0310wal tussinGuaifenesin

    Trademark Results [Rompe Pecho]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ROMPE PECHO
    ROMPE PECHO
    75616526 2346815 Live/Registered
    CULEBRA HOLDINGS, LLC
    1999-01-06
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